Patents, Ethics and Stem Cell Research : The Case of hESC Innovation in Australia, Europe and the United States

Embryonic stem cells offer potentially a ground-breaking insight into health and diseases and are said to offer hope in discovering cures for many ailments unimaginable few years ago. Human embryonic stem cells are undifferentiated, immature cells that possess an amazing ability to develop into almost any body cell such as heart muscle, bone, nerve and blood cells and possibly even organs in due course. This remarkable feature, enabling embryonic stem cells to proliferate indefinitely in vitro (in a test tube), has branded them as a so-called miracle cure . Their potential use in clinical applications provides hope to many sufferers of debilitating and fatal medical conditions. However, the emergence of stem cell research has resulted in intense debates about its promises and dangers. On the one hand, advocates hail its potential, ranging from alleviating and even curing fatal and debilitating diseases such as Parkinson s, diabetes, heart ailments and so forth. On the other hand, opponents decry its dangers, drawing attention to the inherent risks of human embryo destruction, cloning for research purposes and reproductive cloning eventually. Lately, however, the policy battles surrounding human embryonic stem cell innovation have shifted from being a controversial research to scuffles within intellectual property rights. In fact, the ability to obtain patents represents a pivotal factor in the economic success or failure of this new biotechnology. Although, stem cell patents tend to more or less satisfy the standard patentability requirements, they also raise serious ethical and moral questions about the meaning of the exclusions on ethical or moral grounds as found in European and to an extent American and Australian patent laws. At present there is a sort of a calamity over human embryonic stem cell patents in Europe and to an extent in Australia and the United States. This in turn has created a sense of urgency to engage all relevant parties in the discourse on how best to approach patenting of this new form of scientific innovation. In essence, this should become a highly favoured patenting priority. To the contrary, stem cell innovation and its reliance on patent protection risk turmoil, uncertainty, confusion and even a halt on not only stem cell research but also further emerging biotechnology research and development. The patent system is premised upon the fundamental principle of balance which ought to ensure that the temporary monopoly awarded to the inventor equals that of the social benefit provided by the disclosure of the invention. Ensuring and maintaining this balance within the patent system when patenting human embryonic stem cells is of crucial contemporary relevance. Yet, the patenting of human embryonic stem cells raises some fundamental moral, social and legal questions. Overall, the present approach of patenting human embryonic stem cell related inventions is unsatisfactory and ineffective. This draws attention to a specific question which provides for a conceptual framework for this work. That question is the following: how can the investigated patent offices successfully deal with patentability of human embryonic stem cells? This in turn points at the thorny issue of application of the morality clause in this field. In particular, the interpretation of the exclusions on ethical or moral grounds as found in Australian, American and European legislative and judicial precedents. The Thesis seeks to compare laws and legal practices surrounding patentability of human embryonic stem cells in Australia and the United States with that of Europe. By using Europe as the primary case study for lessons and guidance, the central goal of the Thesis then becomes the determination of the type of solutions available to Europe with prospects to apply such to Australia and the United States. The Dissertation purports to define the ethical implications that arise with patenting human embryonic stem cells and intends to offer resolutions to the key ethical dilemmas surrounding patentability of human embryonic stem cells and other morally controversial biotechnology inventions. In particular, the Thesis goal is to propose a functional framework that may be used as a benchmark for an informed discussion on the solution to resolving ethical and legal tensions that come with patentability of human embryonic stem cells in Australian, American and European patent worlds. Key research questions that arise from these objectives and which continuously thread throughout the monograph are: 1. How do common law countries such as Australia and the United States approach and deal with patentability of human embryonic stem cells in their jurisdictions? These practices are then compared to the situation in Europe as represented by the United Kingdom (first two chapters), the Court of Justice of the European Union and the European Patent Office decisions (Chapter 3 onwards) in order to obtain a full picture of the present patenting procedures on the European soil. 2. How are ethical and moral considerations taken into account at patent offices investigated when assessing patentability of human embryonic stem cell related inventions? In order to assess this part, the Thesis evaluates how ethical issues that arise with patent applications are dealt with by: a) Legislative history of the modern patent system from its inception in 15th Century England to present day patent laws. b) Australian, American and European patent offices presently and in the past, including other relevant legal precedents on the subject matter. c) Normative ethical theories. d) The notion of human dignity used as the lowest common denominator for the interpretation of the European morality clause. 3. Given the existence of the morality clause in form of Article 6(1) of the Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions which corresponds to Article 53(a) European Patent Convention, a special emphasis is put on Europe as a guiding principle for Australia and the United States. Any room for improvement of the European morality clause and Europe s current manner of evaluating ethical tensions surrounding human embryonic stem cell inventions is examined. 4. A summary of options (as represented by Australia, the United States and Europe) available as a basis for the optimal examination procedure of human embryonic stem cell inventions is depicted, whereas the best of such alternatives is deduced in order to create a benchmark framework. This framework is then utilised on and promoted as a tool to assist Europe (as represented by the European Patent Office) in examining human embryonic stem cell patent applications. This method suggests a possibility of implementing an institution solution. 5. Ultimately, a question of whether such reformed European patent system can be used as a founding stone for a potential patent reform in Australia and the United States when examining human embryonic stem cells or other morally controversial inventions is surveyed. The author wishes to emphasise that the guiding thought while carrying out this work is to convey the significance of identifying, analysing and clarifying the ethical tensions surrounding patenting human embryonic stem cells and ultimately present a solution that adequately assesses patentability of human embryonic stem cell inventions and related biotechnologies. In answering the key questions above, the Thesis strives to contribute to the broader stem cell debate about how and to which extent ethical and social positions should be integrated into the patenting procedure in pluralistic and morally divided democracies of Europe and subsequently Australia and the United States.

Bridging East and West : The Establishment of the International Institute for Applied Systems Analysis (IIASA) in the United States Foreign Policy of Bridge Building, 1964-1972.

The dissertation examines the foreign policies of the United States through the prism of science and technology. In the focal point of scrutiny is the policy establishing the International Institute for Applied Systems Analysis (IIASA) and the development of the multilateral part of bridge building in American foreign policy during the 1960s and early 1970s. After a long and arduous negotiation process, the institute was finally established by twelve national member organizations from the following countries: Bulgaria, Canada, Czechoslovakia, Federal Republic of Germany (FRG), France, German Democratic Republic (GDR), Great Britain, Italy, Japan, Poland, Soviet Union and United States; a few years later Sweden, Finland and the Netherlands also joined. It is said that the goal of the institute was to bring together researchers from East and West to solve pertinent problems caused by the modernization process experienced in industrialized world. It originates from President Lyndon B. Johnson s bridge building policies that were launched in 1964, and was set in a well-contested and crowded domain of other international organizations of environmental and social planning. Since the distinct need for yet another organization was not evident, the process of negotiations in this multinational environment enlightens the foreign policy ambitions of the United States on the road to the Cold War détente. The study places this project within its political era, and juxtaposes it with other international organizations, especially that of the OECD, ECE and NATO. Conventionally, Lyndon Johnson s bridge building policies have been seen as a means to normalize its international relations bilaterally with different East European countries, and the multilateral dimension of the policy has been ignored. This is why IIASA s establishment process in this multilateral environment brings forth new information on US foreign policy goals, the means to achieve these goals, as well as its relations to other advanced industrialized societies before the time of détente, during the 1960s and early 1970s. Furthermore, the substance of the institute applied systems analysis illuminates the differences between European and American methodological thinking in social planning. Systems analysis is closely associated with (American) science and technology policies of the 1960s, especially in its military administrative applications, thus analysis within the foreign policy environment of the United States proved particularly fruitful. In the 1960s the institutional structures of European continent with faltering, and the growing tendencies of integration were in flux. One example of this was the long, drawn-out process of British membership in the EEC, another is de Gaulle s withdrawal from NATO s military-political cooperation. On the other hand, however, economic cooperation in Europe between East and West, and especially with the Soviet Union was expanding rapidly. This American initiative to form a new institutional actor has to be seen in that structural context, showing that bridge building was needed not only to the East, but also to the West. The narrative amounts to an analysis of how the United States managed both cooperation and conflict in its hegemonic aspirations in the emerging modern world, and how it used its special relationship with the United Kingdom to achieve its goals. The research is based on the archives of the United States, Great Britain, Sweden, Finland, and IIASA. The primary sources have been complemented with both contemporary and present day research literature, periodicals, and interviews.

The State of Coral Reef Ecosystems of the United States and Pacific Freely Associated States: 2005

Executive Summary: For over three decades, scientists have been documenting the decline of coral reef ecosystems, amid increasing recognition of their value in supporting high biological diversity and their many benefits to human society. Coral reef ecosystems are recognized for their benefits on many levels, such as supporting economies by nurturing fisheries and providing for recreational and tourism opportunities, providing substances useful for medical purposes, performing essential ecosystem services that protect against coastal erosion, and provid-ing a diversity of other, more intangible contributions to many cultures. In the past decade, the increased awareness regarding coral reefs has prompted action by governmental and non-governmental organizations, including increased funding from the U.S. Congress for conservation of these important ecosystems and creation of the U.S. Coral Reef Task Force (USCRTF) to coordinate activities and implement conservation measures [Presidential Executive Order 13089]. Numerous partnerships forged among Federal agencies and state, local, non-governmental, academic and private partners support activities that range from basic science to systematic monitoring of ecosystem com-ponents and are conducted by government agencies, non-governmental organizations, universities, and the private sector. This report shares the results of many of these efforts in the framework of a broad assessment of the condition of coral reef ecosystems across 14 U.S. jurisdictions and Pacific Freely Associated States. This report relies heavily on quantitative, spatially-explicit data that has been collected in the recent past and comparisons with historical data, where possible. The success of this effort can be attributed to the dedication of over 160 report contributors who comprised the expert writing teams for each jurisdiction. The content of the report chapters are the result of their considerable collaborative efforts. The writing teams, which were organized by jurisdiction and comprised of experts from numerous research and management institutions, were provided a basic chapter outline and a length limit, but the content of each chapter was left entirely to their discretion. Each jurisdictional chapter in the report is structured to: 1) describe how each of the primary threats identified in the National Coral Reef Action Strategy (NCRAS) has manifested in the jurisdiction; 2) introduce ongoing monitoring and assessment activities relative to three major categories of inquiry – water quality, benthic habitats, and associated biological communities – and provide summary results in a data-rich format; and 3) highlight recent management activities that promote conservation of coral reef ecosystems.

National perspectives on climate change adaptation: A panel discussion of climate change adaptation efforts in diverse coastal regions of the United States

Climate change has rapidly emerged as a significant threat to coastal areas around the world. While uncertainty regarding distribution, intensity, and timescale inhibits our ability to accurately forecast potential impacts, it is widely accepted that changes in global climate will result in a variety of significant environmental, social, and economic impacts. Coastal areas are particularly vulnerable to the effects of climate change and the implications of sea-level rise, and coastal communities must develop the capacity to adapt to climate change in order to protect people, property, and the environment along our nation’s coasts. The U.S. coastal zone is highly complex and variable, consisting of several regions that are characterized by unique geographic, economic, social and environmental factors. The degree of risk and vulnerability associated with climate change can vary greatly depending on the exposure and sensitivity of coastal resources within a given area. The ability of coastal communities to effectively adapt to climate change will depend greatly on their ability to develop and implement feasible strategies that address unique local and regional factors. A wide variety of resources are available to assist coastal states in developing their approach to climate change adaptation. However, given the complex and variable nature of the U.S. coastline, it is unlikely that a single set of guidelines can adequately address the full range of adaptation needs at the local and regional levels. This panel seeks to address some of the unique local and regional issues facing coastal communities throughout the U.S. including anticipated physical, social, economic and environmental impacts, existing resources and guidelines for climate change adaptation, current approaches to climate change adaptation planning, and challenges and opportunities for developing adaptation strategies. (PDF contains 4 pages)

Guidelines for the conservation and restoration of seagrasses in the United States and adjacent waters

Seagrass ecosystems are protected under the federal "no-net-loss" policy for wetlands and form one of the most productive plant communities on the planet, performing important ecological functions. Seagrass beds have been recognized as a valuable resource critical to the health and function of coastal waters. Greater awareness and public education, however, is essential for conservation of this resource. Tremendous losses of this habitat have occurred as a result of development within the coastal zone. Disturbances usually kill seagrasses rapidly, and recovery is often comparatively slow. Mitigation to compensate for destruction of existing habitat usually follows when the agent of loss and responsible party are known. Compensation assumes that ecosystems can be made to order and, in essence, trades existing functional habitat for the promise of replacement habitat. While ~lant ingse agrass is not technically complex, there is no easy way to meet the goal of maintaining or increasing seagrass acreage. Rather, the entire process of planning, planting and monitoring requires attention to detail and does not lend itself to oversimplification.

The state of coral reef ecosystems of the United States and Pacific Freely Associated States: 2008

In the past decade, increased awareness regarding the declining condition of U.S. coral reefs has prompted various actions by governmental and non-governmental organizations. Presidential Executive Order 13089 created the U.S. Coral Reef Task Force (USCRTF) in 1998 to coordinate federal and state/territorial activities (Clinton, 1998), and the Coral Reef Conservation Act of 2000 provided Congressional funding for activities to conserve these important ecosystems, including mapping, monitoring and assessment projects carried out through the support of NOAA’s CRCP. Numerous collaborations forged among federal agencies and state, local, non-governmental, academic and private partners now support a variety of monitoring activities. This report shares the results of many of these monitoring activities, relying heavily on quantitative, spatially-explicit data that has been collected in the recent past and comparisons with historical data where possible. The success of this effort can be attributed to the dedication of over 270 report contributors who comprised the expert writing teams in the jurisdictions and contributed to the National Level Activities and National Summary chapters. The scope and content of this report are the result of their dedication to this considerable collaborative effort. Ultimately, the goal of this report is to answer the difficult but vital question: what is the condition of U.S. coral reef ecosystems? The report attempts to base a response on the best available science emerging from coral reef ecosystem monitoring programs in 15 jurisdictions across the country. However, few monitoring programs have been in place for longer than a decade, and many have been initiated only within the past two to five years. A few jurisdictions are just beginning to implement monitoring programs and face challenges stemming from a lack of basic habitat maps and other ecosystem data in addition to adequate training, capacity building, and technical support. There is also a general paucity of historical data describing the condition of ecosystem resources before major human impacts occurred, which limits any attempt to present the current conditions within an historical context and contributes to the phenomenon of shifting baselines (Jackson, 1997; Jackson et al., 2001; Pandolfi et al., 2005).

The law of the sea: the United States, Canada and the deep seabed

The Falkland Islands War of 1982 was fought over competing claims to sovereignty over a group of islands off the east coast of South America. The dispute was between Argentina and the United Kingdom. Argentina claims the islands under rights to Spanish succession, the fact that they lie off the Argentine coast line and that in 1833 Great Britain took the islands illegally and by force. The United Kingdom claims the islands primarily through prescription--the fact that they have governed the islands in a peaceful, continuous and public manner since 1833. The British also hold that the population living on the islands, roughly eighteen hundred British descendants, should be able to decide their own future. The United Kingdom also lays claim to the islands through rights of discovery and settlement, although this claim has always been challenged by Spain who until 1811 governed the islands. Both claims have legal support, and the final decision if there will ever be one is difficult to predict. Sadly today the ultimate test of sovereignty does not come through international law but remains in the idea that "He is sovereign who can defend his sovereignty." The years preceding the Argentine invasion of 1982 witnessed many diplomatic exchanges between The United Kingdom and Argentina over the future of the islands. During this time the British sent signals to Argentina that ii implied a decline in British resolve to hold the islands and demonstrated that military action did more to further the talks along than did actual negotiations. The Argentine military junta read these signals and decided that they could take the islands in a quick military invasion and that the United Kingdom would consider the act as a fait accompli and would not protest the invasion. The British in response to this claimed that they never signaled to Argentina that a military solution was acceptable to them and launched a Royal Navy task force to liberate the islands. Both governments responded to an international crisis with means that were designed both to resolve the international crisis and increase the domestic popularity of the government. British Prime Minister Margaret Thatcher was facing an all-time low in popularity for post-War Prime Ministers while Argentine President General Galtieri needed to gain mass popular support so he could remain a viable President after he was scheduled to lose command of the army and a seat on the military junta that ran the country. The military war for the Falklands is indicative of the nature of modern warfare between Third World countries. It shows that the gap in military capabilities between Third and First World countries is narrowing significantly. Modern warfare between a First and Third World country is no longer a 'walk over' for the First World country.

Letter from the Secretary of the Navy, transmitting the official account of the capture of the British sloop of War, Reindeer, by the United States sloop Wasp, commanded by Captain Johnston Blakeley, on the twenty-eighth June last.--

"A list of British vessels captured by the United States' sloop of War Wasp, J. Blakeley esg. commander, between May 1st and July 6th, 1814".Folded table at end.

Message from the President of the United States, in relation to the claim of Virginia, an account of interest paid by that State, on moneys borrowed for the payment of the militia thereof, for services rendered the United States.--

April 13, 1824. Printed by order of the Senate of the United States.

Message from the President of the United States, transmitting of a report of the Secretary of State, in relation to individuals selected from American prisoners of war, and sent to Great Britain for trial, and also in relation to any orders for retaliation, &c., &c.--

April 16, 1814. Printed by order of the Senate of the United States.

Report of the Committee to whom was Referred the Correspondence between Mr. Monroe and Mr. Canning, and between Mr. Madison and Mr. Rose, relative to the attacked of Chesapeake : and also a communication from the President of the United States of the 30 March last, with a letter from Mr. Erskine to the Secretary of State, and a letter from M. Champagny to Gen. Armstrong.--

April 16, 1808. Printed by Order of the Senate.

In Senate of the United States: February 27, 1816

Caption title: [U.S. 14th Congress, 1st session. Senate Doc. 55].

Letter from the Secretary of the Navy, transmitting the official account of the capture of the British sloop of War, Reindeer, by the United States sloop Wasp, commanded by Captain Johnston Blakeley, on the twenty-eighth June last

"A list of British vessels captured by the United States' sloop of War Wasp, J. Blakeley esg. commander, between May 1st and July 6th, 1814".Folded table at end. October 17, 1814. Printed by order of the Senate of the United States.

Message from the President of the United States to both Houses of Congress at the commencement of the second session of the twelfth Congress

November 4, 1812. Read, and ordered to be printed. Includes Documents accompanying the Message of the President of the United States to the two Houses of Congress, at the opening of the second session of the twelfth Congress United States. 12th Congress, 2nd session, 1812-1813. House.; United States. 12th Congress, 2nd session, 1812-1813. Senate.; United States. Congress. House.; United States. Congress. Senate. Printed by A. and C. Way

The Flags, Standards and Colors Taken by the Forces of the United States

Full Title: Report of the Committee appointed to inquire into the Present condition and distribution of the flags, standards and colors, which have been taken by the forces of the United States from their enemies, and whether it would be expedient to make any provision in relation to them Adam Seybet, Chairman. Exhibit folded at end of text. February 4, 1814. Read, and committed to a committee of the whole House on Monday next. Printed by A and G Way